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Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00836043
First received: February 2, 2009
Last updated: July 28, 2010
Last verified: July 2010
History of Changes
  Purpose

This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.


Condition Intervention
Chronic Lymphocytic Leukemia
 Drug: Alemtuzumab (MabCampath)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables. [ Time Frame: After first cycle of treatment, e.g. 12 weeks, then after 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Alemtuzumab (MabCampath)
Intravenous therapy according to product information.
Other Name: BAY86-5045

Detailed Description:

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)

Criteria

Inclusion Criteria:

In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.

Exclusion Criteria:

In accordance with Summaries of Product Characteristics (SPC).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836043

Locations
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Israel
Many Locations, Israel
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00836043     History of Changes
Other Study ID Numbers: 13418, 13858, 14241, MC0701, STAR
Study First Received: February 2, 2009
Last Updated: July 28, 2010
Health Authority: Bosnia: Federal Ministry of Health
Jordan: Ethical Committee
Romania: State Institute for Drug Control
Serbia: Ethics Committee
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Croatia: Ministry of Science, Education and Sports
Ukraine: Ministry of Health
Macedonia: Ministry of Health
Morocco: Ministry of Public Health
Turkey: Ethics Committee
Turkey: Ministry of Health
Israel: Ethics Commission

Keywords provided by Genzyme:
CLL
alemtuzumab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013